Endoluminal anastomosis and tissue closure devices

ABSTRACT

Multiple endoscopic devices and methods for closing perforations and/or creating anastomoses in tissue are described. For example, this document provides devices and methods for performing esophagogastric anastomoses and for closing esophageal perforations in a minimally invasive fashion. The devices and methods provided herein can also be used for, without limitation, colorectal anastomoses, any bowel anastomosis, gastric bypass anastomoses, and broader vessel anastomoses.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.15/750,909, filed Feb. 7, 2018, which is a National Stage applicationunder 35 U.S.C. § 371 of International Application No.PCT/US2016/041700, having an International Filing Date of Jul. 11, 2016,which claims the benefit of U.S. Provisional Ser. No. 62/202,447 filedAug. 7, 2015. The disclosure of the prior applications are consideredpart of and are incorporated by reference in the disclosure of thisapplication.

BACKGROUND 1. Technical Field

This document relates to devices and methods for closing perforationsand/or creating anastomoses in tissue. For example, this documentrelates to devices and methods for performing esophagogastricanastomoses and for closing esophageal perforations in a minimallyinvasive fashion.

2. Background Information

An estimated 14,500 patients are diagnosed with esophageal cancer in theUnited States every year. The standard of care for patients withlocalized disease is resection. Although mortality rates in esophagealcancer patients undergoing esophagectomy appear to be decreasing,morbidity is still significant. Anastomotic complications have anegative effect on patient survival. Postoperative leak, dysphagia, andstricture may be indicators of the quality of an anastomosis.

The current standard of care for patients undergoing esophagectomyincludes the performance of an intrathoracic esophagogastric anastomosisprocedure. There are three conventional intrathoracic methods forperforming such an esophagogastric anastomosis. First is theside-to-side stapled esophagogastric anastomosis. Second is thecircular-stapled esophagogastric anastomosis technique. Third is thehand-sewn esophagogastric anastomosis technique. Each of thesetechniques is surgically invasive. Hence, a need exists for a minimallyinvasive esophagogastric anastomosis technique.

SUMMARY

This document provides devices and methods for closing perforationsand/or creating anastomoses in tissue. For example, this documentprovides devices and methods for performing esophagogastric anastomosesand for closing esophageal perforations in a minimally invasive fashion.The devices and methods provided herein can also be used for, withoutlimitation, colorectal anastomoses, any bowel anastomosis, gastricbypass anastomoses, and broader vessel anastomoses.

In one implementation, an endoscopic anastomosis device includes anendoscope with a plurality of working channels therethrough, a pluralityof T-fasteners, and a plurality of sutures. Each T-fastener of theplurality of T-fasteners is slidably disposable within a working channelof the plurality of working channels. Each T-fastener of the pluralityof T-fasteners has a suture of the plurality of sutures attachedthereto. Distal end portions of each working channel of the plurality ofworking channels are configured to direct T-fasteners to emerge at leastsomewhat laterally from a distal tip portion of the endoscope.

Such an endoscopic anastomosis device may optionally include one or moreof the following features. The distal tip portion of the endoscope maycomprise a tapered leading end. The device may further comprise one ormore pusher catheters that are slidably disposable within each workingchannel of the plurality of working channels. Each T-fastener of theplurality of T-fasteners may have a beveled tip configured forpuncturing tissue. Distal end portions of each working channel of theplurality of working channels may be configured to direct T-fasteners toemerge laterally at an angle from between about 45 degrees to about 90degrees in relation to a longitudinal axis of the endoscope.

In another implementation, a method of endoscopically creating ananastomosis between two body conduits of a patient includes deploying anendoscope anastomosis device within the patient such that the endoscopeanastomosis device is within an interior of each body conduit of the twobody conduits, ejecting a first grouping of T-fasteners from at leastsome working channels of the plurality of working channels, ejecting asecond grouping of T-fasteners from at least some working channels ofthe plurality of working channels, and cinching individual T-fastenersof the first grouping of T-fasteners together with respective individualT-fasteners of the second grouping of T-fasteners so as to draw thefirst body conduit into contact with the second body conduit. Theendoscope anastomosis device includes an endoscope with a plurality ofworking channels therethrough; a plurality of T-fasteners, eachT-fastener of the plurality of T-fasteners being slidably disposablewithin a working channel of the plurality of working channels; and aplurality of sutures. Each T-fastener of the plurality of T-fastenershas a suture of the plurality of sutures attached thereto. Distal endportions of each working channel of the plurality of working channelsare configured to direct T-fasteners to emerge at least somewhatlaterally from a distal tip portion of the endoscope. The ejecting thefirst grouping of T-fasteners causes the first grouping of T-fastenersto puncture through a first body conduit of the two body conduits. Theejecting the second grouping of T-fasteners causes the second groupingof T-fasteners to puncture through a second body conduit of the two bodyconduits.

Such a method of endoscopically creating an anastomosis between two bodyconduits of a patient may optionally include one or more of thefollowing features. The distal tip portion of the endoscope may includea tapered leading end. The ejecting the first grouping of T-fastenersmay involve pushing the first grouping of T-fasteners out from the atleast some working channels of the plurality of working channels. Theejecting the second grouping of T-fasteners may involve pushing thesecond grouping of T-fasteners out from the at least some workingchannels of the plurality of working channels. Each T-fastener of theplurality of T-fasteners may have a beveled tip configured forpuncturing tissue. Distal end portions of each working channel of theplurality of working channels may be configured to direct T-fasteners toemerge laterally at an angle from between about 45 degrees to about 90degrees in relation to a longitudinal axis of the endoscope. Thecinching may be performed using suture knots and a suture knot pusherdevice. The cinching may be performed using suture closure clip devices.The two body conduits may be portions of an esophagus.

In another implementation, a method of closing an opening in a bodyconduit of a patient includes deploying an endoscope device within thepatient such that the endoscope device is within an interior of the bodyconduit and such that a distal tip portion of the endoscope is proximateto the opening; ejecting a first T-fastener away from the endoscope suchthat the first T-fastener emerges at least somewhat laterally away froma longitudinal axis of the endoscope, and such that the first T-fastenerproceeds through a wall of the body conduit adjacent to the opening;ejecting a second T-fastener away from the endoscope such that thesecond T-fastener emerges at least somewhat laterally away from thelongitudinal axis of the endoscope, and such that the second T-fastenerproceeds through the wall of the body conduit adjacent to the openingand generally on an opposite side of the opening in comparison to thefirst T-fastener; and cinching a first suture that is attached to thefirst T-fastener with a second suture that is attached to the secondT-fastener so as to draw the first T-fastener and the second T-fastenertowards each other and to thereby at least partly close the opening.

Such a method of closing an opening in a body conduit of a patient mayoptionally include one or more of the following features. An overtubemay be slidably disposed within a working channel of the endoscope, andat least one of the first T-fastener or the second T-fastener may beejected from the overtube. The overtube may be used to puncture the wallof the body conduit to create one or more incisions through which leastone of the first T-fastener or the second T-fastener proceed. The bodyconduit may be an esophagus.

In another implementation, a system for creating an anastomosis includesa bougie, an obturator extending from a distal end of the bougie, astent releasably disposable about at least a portion of the obturator, asheath that is slidably engageable with the bougie, and a plurality ofT-fasteners. The sheath includes a distal end portion configured forcovering at least a portion of the stent while the stent is disposedabout the obturator. The obturator includes a portion having an outerdiameter relief area. Each of the plurality of T-fasteners areconfigured to pass through a wall of the stent. A portion of each of theplurality of T-fasteners are sized to fit within the portion having anouter diameter relief area.

Such a system for creating an anastomosis may optionally include one ormore of the following features. The stent may be bioresorbable,biodegradable, or bioabsorbable. The obturator may include one or moreindicator lights positioned to indicate a location of the portion havingan outer diameter relief area.

In another implementation, a method of creating an anastomosis in apatient includes: (a) installing at least a portion of a bougie withinan obturator extending from a distal end of the bougie into a first bodyconduit of the patient (a stent is releasably disposed about at least aportion of the obturator), (b) installing an end portion of the firstbody conduit into engagement with a second body tissue structure of thepatient, (c) sliding a sheath (the sheath is slidably engaged with thebougie and covers at least a portion of the stent) proximally inrelation to the bougie so that the stent is no longer covered by thesheath, (d) installing a plurality of T-fasteners, and (e) removing thebougie and obturator from the patient while leaving the stent that isattached to the first body conduit and the second body tissue structurewithin the patient. The portion of the obturator includes an outerdiameter relief area. At least some T-fasteners of the plurality ofT-fasteners extend through each of: (i) a wall of the first bodyconduit, (ii) a wall of the second body tissue structure, (iii) a wallof the stent, and into the outer diameter relief area.

Such a method of creating an anastomosis in a patient may optionallyinclude one or more of the following features. The first body conduitmay be an esophagus and the second body tissue structure may be astomach. The first body conduit and the second body tissue structure maybe parts of the patient's vasculature. The first body conduit and thesecond body tissue structure may be parts of the patient's lower GItract.

Particular embodiments of the subject matter described in this documentcan be implemented to realize one or more of the following advantages.In some embodiments of the devices and methods provided herein, aminimally invasive esophagogastric anastomosis procedure can beperformed. Such minimally invasive techniques can reduce recovery times,patient discomfort, and treatment costs. Additionally, some embodimentsthe devices and methods provided herein can also be used to closeesophageal perforations, tears, and other types of openings in aminimally invasive fashion.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention pertains. Although methods and materialssimilar or equivalent to those described herein can be used to practicethe invention, suitable methods and materials are described herein. Allpublications, patent applications, patents, and other referencesmentioned herein are incorporated by reference in their entirety. Incase of conflict, the present specification, including definitions, willcontrol. In addition, the materials, methods, and examples areillustrative only and not intended to be limiting.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description herein. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims. While this specificationcontains many specific implementation details, these should not beconstrued as limitations on the scope of any invention or of what may beclaimed, but rather as descriptions of features that may be included inone or more particular embodiments.

DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate a patient undergoing a minimally invasiveprocedure to close an esophageal opening using an endoscopic T-fastenertissue closure device in accordance with some embodiments providedherein.

FIGS. 2-4 are a series of illustrations showing steps of the process ofclosing the esophageal perforation using the devices and methods ofFIGS. 1A and 1B in accordance with some embodiments provided herein.

FIGS. 5A and 5B illustrate a patient undergoing an example minimallyinvasive procedure to create an esophagogastric anastomosis using anendoscopic T-fastener anastomosis device in accordance with someembodiments provided herein.

FIGS. 6-12 are a series of illustrations showing steps of the process ofcreating the esophagogastric anastomosis using the devices and methodsof FIGS. 5A and 5B in accordance with some embodiments provided herein.

FIGS. 13A and 13B illustrate a patient undergoing another exampleminimally invasive esophagogastric anastomosis procedure to create astent-reinforced esophagogastric anastomosis in accordance with someembodiments provided herein.

FIGS. 14-17 are a series of illustrations showing steps of the processof creating the esophagogastric anastomosis using the devices andmethods of FIGS. 13A and 13B in accordance with some embodimentsprovided herein.

Like reference numbers represent corresponding parts throughout.

DETAILED DESCRIPTION

This document provides devices and methods for closing perforationsand/or creating anastomoses in tissue. For example, this documentprovides devices and methods for performing esophagogastric anastomosesand for closing esophageal perforations in a minimally invasive fashion.The devices and methods provided herein may also be used to treat otherconditions, and to treat other areas of the body in addition to theesophagus. For example, the devices and methods provided herein may beused to create anastomoses or close openings in the lower GI tract,vasculature, and respiratory system, to provide some additionalexamples. The devices and methods provided herein may also be used forgastric bypass anastomoses and other like procedures.

Referring to the example of FIGS. 1A and 1B, a human patient 10 canreceive a treatment to close an esophageal opening 14 using anendoscopic T-fastener tissue closure device 100 in accordance with someembodiments provided herein. In the depicted embodiment, tissue closuredevice 100 includes an overtube 110 through which one or moreT-fasteners 120 a that are attached to a suture 122 a can be deployed.Overtube 110 is slidably disposed within a channel of an endoscope 130.

Endoscope 130 can be inserted within esophagus 12 of patient 10.Endoscope 130 can then be navigated within esophagus 12 so that thedistal end of endoscope 130 is positioned in a desired proximity toopening 14. In the depicted embodiment, overtube 110 is then expressedfrom endoscope 130 in preparation for installing T-fastener 120.

In some embodiments, overtube 110 has a distal tip portion 112 that isconfigured for puncturing through esophagus 12. For example, in thedepicted embodiment distal tip portion 112 of overtube 110 is beveled tocreate a sharp tip for puncturing through esophagus 12. In addition, inthe depicted embodiment distal tip portion 112 is flexibly radiused sothat the tip of distal tip portion 112 is oriented at a steep angle inrelation to esophagus 12, thereby facilitating puncture of distal tipportion 112 through esophagus 12.

In alternative embodiments, T-fastener 120 a itself is the element thatpunctures through esophagus 12. In some such embodiments, T-fastener 120a is configured with a sharp leading end that facilitates puncture ofT-fastener 120 a through esophagus 12. In some embodiments, an overtube(such as, but not limited to, overtube 110) is used to orient T-fastener120 a in relation to esophagus 12 so that T-fastener 120 a can puncturethrough esophagus 12. In some embodiments, rather than using anovertube, endoscope 130 may include one or more working channels thatorient T-fastener 120 a in relation to esophagus 12 so that T-fastener120 a can puncture through esophagus 12 (e.g., refer to FIG. 6 ).

In some embodiments, T-fastener 120 a is pushed to emerge (or eject)from overtube 110 or endoscope 130 using a pusher catheter (not shown).In some embodiments, T-fastener 120 a is pushed to emerge from overtube110 or endoscope 130 using a lever mechanism as known in the art ofendoscopic instruments.

After puncturing esophagus 12, T-fastener 120 a is positioned on theexterior wall of esophagus 12. Suture 122 a, being previously attachedto T-fastener 120 a, extends from T-fastener 120 a, through overtube 110and endoscope 130, and terminates at a free end that is external topatient 10 (through the mouth).

Referring also to FIG. 2 , T-fastener 120 a is shown installed adjacentto opening 14. In addition, a second T-fastener 120 b is shown installedadjacent to opening 14 generally opposite to T-fastener 120 a.T-fastener 120 b can be installed using any of the techniques describedabove in relation to T-fastener 120 a.

In some embodiments, T-fastener 120 b is deployed from the same overtube110 or working channel of endoscope 130 as T-fastener 120 a was deployedfrom. In some embodiments, T-fastener 120 b is deployed from a differentovertube 110 or different working channel of endoscope 130 as T-fastener120 a was deployed from.

A suture 122 b is attached to T-fastener 120 b. In a manner analogous tosuture 122 a, in some embodiments suture 122 b extends from T-fastener120 b, through overtube 110 and/or endoscope 130, and terminates at afree end that is external to patient 10 (i.e., through the mouth).

While in the depicted example implementation, opening 14 is closeableusing two T-fasteners 120 a-b, it should be understood that, using theinventive concepts provided herein, in some implementations more thantwo T-fasteners 120 a-b can be installed to close an opening. Forinstance, larger openings may require more than two T-fasteners 120 a-b.In addition, irregularly shaped openings may require more than twoT-fasteners 120 a-b. Further, other types of implementations may requiremore than two T-fasteners 120 a-b. All such implementations areenvisioned within the scope of this disclosure, and the inventiveconcepts provided herein can be applied to provide effective,advantageous, and novel treatments for such implementations.

Referring to FIGS. 3 and 4 , with T-fasteners 120 a-b installed onopposite sides of opening 14, then sutures 122 a-b can be cinchedtightly together to close opening 14. Thereafter, sutures 122 a-b can betrimmed and the unattached portions can be withdrawn from esophagus 12,along with endoscope 130 and any other associated instruments.

In the depicted implementation, a knot pusher 140 is being used to cinchsutures 122 a-b snugly together. In the depicted implementation, knotpusher 140 is deployed down a working channel of endoscope 130 (i.e.,the same working channel that sutures 122 a-b reside in). Alternatively,in some implementations endoscope 130 is withdrawn after placement ofT-fasteners 120 a-b, but prior to cinching sutures 122 a-b. In such acase, knot pusher 140 can be deployed down esophagus 12 without beingconfined within endoscope 130. Knot pusher 140 can be used to tightenmultiple knots between sutures 122 a-b, to thereby securely and durablyclose opening 14.

In some embodiments, a suture closure clip device can be used on sutures122 a-b to cinch T-fasteners 120 a-b together, as an alternative totying knots in sutures 122 a-b. In some such embodiments, the sutureclosure clip device can be pushed along sutures 122 a-b and towardsT-fasteners 120 a-b and then used to snug T-fasteners 120 a-b closetogether. Alternatively, in some embodiments the suture closure clipdevice can be installed around sutures 122 a-b near opening 14 and thenclamped tightly onto sutures 122 a-b after sutures 122 a-b are pulledtight to draw T-fasteners 120 a-b together.

Referring to FIGS. 5A and 5B, in this depiction patient 10 has had anesophagectomy. Accordingly, patient 10 is receiving a minimally invasivetreatment to create an anastomosis between an esophagus end portion 12 aand an esophagus end portion 12 b using an endoscopic anastomosis device200 in accordance with some embodiments provided herein.

Referring also to FIG. 6 , endoscopic anastomosis device 200 includes adistal tip portion 202 with a tapered leading end. The tapered leadingend of distal tip portion 202 can be advantageously used to gain accesswithin esophagus end portion 12 b, and to atraumatically be advancedwithin esophagus 12 in general.

Endoscopic anastomosis device 200 also includes one or more workingchannels, such as channels 210 a, 210 b, and 210 c. In the depictedembodiment, only three channels 210 a, 210 b, and 210 c are shown forease of understanding. However, it should be understood that the workingchannels will be distributed around the circumference of distal tipportion 202. In general, while it is not a requirement, the workingchannels will be distributed around the circumference of distal tipportion 202 in even angular increments. For example, when ten (10)working channels are included, the working channels may be distributedat increments of about 36° between each other so as to evenly distributethe working channels around the circumference of distal tip portion 202in even angular increments.

In some embodiments, ten working channels are included. Alternatively,in some embodiments four, five, six, seven, eight, nine, eleven, twelve,thirteen, fourteen, fifteen, sixteen, seventeen, eighteen, nineteen,twenty, or more than twenty working channels are included.

In some embodiments, the ends of channels 210 a, 210 b, and 210 c atdistal tip portion 202 are curved so as to direct T-fasteners to emerge(i.e., eject) laterally from endoscopic anastomosis device 200 (inrelation to the longitudinal axis of the endoscopic anastomosis device200). In some embodiments, the ends of channels 210 a, 210 b, and 210 cat distal tip portion 202 are curved so as to direct T-fasteners toemerge from endoscopic anastomosis device 200 at a steep angle (e.g.,about 45° to about 90°) relative to the walls of esophagus end portion12 a and esophagus end portion 12 b. In some embodiments, the ends ofchannels 210 a, 210 b, and 210 c at distal tip portion 202 are curved soas to direct T-fasteners to emerge from endoscopic anastomosis device200 essentially perpendicularly relative to the walls of esophagus endportion 12 a and esophagus end portion 12 b. Such an angle of emergencecan help facilitate the T-fasteners to puncture the walls of esophagusend portion 12 a and esophagus end portion 12 b. In some embodiments,overtubes can be slidably disposed within channels 210 a, 210 b, and 210c (as in the manner described above in reference to overtube 110 used inconjunction with endoscopic T-fastener tissue closure device 100).

Referring to FIG. 7 , with distal tip portion 202 within esophagus endportion 12 b, T-fasteners 220 a, 220 b, and 220 c can be pushed toemerge from channels 210 a, 210 b, and 210 c, and to penetrate throughesophagus end portion 12 b. In some embodiments, T-fasteners 220 a, 220b, and 220 c have a beveled tip to facilitate penetration throughesophagus end portion 12 b. In some embodiments, T-fasteners 220 a, 220b, and 220 c are essentially triangular, with a pointed tip forpenetration and a widen base for tissue apposition.

In some embodiments, T-fasteners 220 a, 220 b, and 220 c are pushed toemerge from channels 210 a, 210 b, and 210 c using pusher catheters (notshown). In some embodiments, T-fasteners 220 a, 220 b, and 220 c arepushed to emerge from channels 210 a, 210 b, and 210 c using a levermechanism as known in the art of endoscopic instruments.

While in the depicted embodiment channels 210 a, 210 b, and 210 c directT-fasteners 220 a, 220 b, and 220 c to emerge from the tapered leadingend of distal tip portion 202, in some embodiments channels 210 a, 210b, and 210 c are designed differently so as to direct T-fasteners 220 a,220 b, and 220 c to emerge from a non-tapered portion of distal tipportion 202.

Referring to FIG. 8 , after installation of T-fasteners 220 a, 220 b,and 220 c in esophagus end portion 12 b, distal tip portion 202 can bepulled back to position it in preparation for installing T-fasteners inesophagus end portion 12 a. In this view, sutures 222 a, 222 b, and 222c that are attached to T-fasteners 220 a, 220 b, and 220 c respectivelyare clearly in view. In a manner analogous to sutures 122 a and 122 bdescribed above in reference to endoscopic T-fastener tissue closuredevice 100, sutures 222 a, 222 b, and 222 c extend from T-fasteners 220a, 220 b, and 220 c, through endoscopic anastomosis device 200, andterminate at a free ends that are external to patient 10 (i.e., throughthe mouth).

Referring to FIG. 9 , with distal tip portion 202 now in positionrelative to esophagus end portion 12 a, T-fasteners 220 d, 220 e, and220 f can be deployed from endoscopic anastomosis device 200. In thedepicted embodiment, T-fasteners 220 d, 220 e, and 220 f are pushed toemerge from channels 210 a, 210 b, and 210 c (the same channels asT-fasteners 220 a, 220 b, and 220 c respectively). Alternatively, insome embodiments T-fasteners 220 d, 220 e, and 220 f can be pushed toemerge from other channels that are adjacent to but distinct fromchannels 210 a, 210 b, and 210 c.

In some embodiments, T-fasteners 220 d, 220 e, and 220 f are manuallyloaded into channels 210 a, 210 b, and 210 c after the deployment ofT-fasteners 220 a, 220 b, and 220 c. In some embodiments, endoscopicanastomosis device 200 is configured to use a T-fastener cartridge withtwo or more tranches (groupings) of T-fasteners therein. Accordingly, afirst tranche of T-fasteners (e.g., T-fasteners 220 a, 220 b, and 220 c)can be deployed in esophagus end portion 12 b, and a second tranche ofT-fasteners (e.g., T-fasteners 220 d, 220 e, and 2200 can be deployed inesophagus end portion 12 a.

Referring to FIGS. 10-12 , sutures 222 d, 222 e, and 222 f are attachedto T-fasteners 220 d, 220 e, and 220 f respectively. After deployment ofall T-fasteners 220 a, 220 b, 220 c, 220 d, 220 e, and 220 e,preparations can be made to cinch suture 222 a with suture 222 d, suture222 b with suture 222 e, and suture 222 c with suture 222 f.

In the depicted implementation, endoscopic anastomosis device 200 iswithdrawn prior to cinching the sutures. Thereafter, suture closure clipdevices 224 a, 224 b, and 224 c are installed to cinch togetherT-fastener 220 a with T-fastener 220 d, T-fastener 220 b with T-fastener220 e, and T-fastener 220 c with T-fastener 220 f. However, in someimplementations endoscopic anastomosis device 200 remains in place andsuture knots or suture closure clip devices are advanced throughchannels 210 a, 210 b, and 210 c towards T-fasteners 220 a, 220 b, 220c, 220 d, 220 e, and 220 e. In any case, sutures knots or suture closureclip devices 224 a, 224 b, and 224 c draw together T-fastener 220 a withT-fastener 220 d, T-fastener 220 b with T-fastener 220 e, and T-fastener220 c with T-fastener 220 f The drawing together of T-fastener 220 awith T-fastener 220 d, T-fastener 220 b with T-fastener 220 e, andT-fastener 220 c with T-fastener 220 f creates an anastomosis betweenesophagus end portion 12 a and esophagus end portion 12 b. Sutures 222a, 222 b, 222 c, 222 d, 222 e, and 222 f can then be trimmed and theunattached portions can be withdrawn from esophagus 12, along withendoscopic anastomosis device 200 and any other associated instruments.

Referring to the example of FIGS. 13A and 13B, in this depiction patient10 has had an esophagectomy of the lower esophagus 12. Accordingly,patient 10 is receiving a minimally invasive treatment to create ananastomosis between an esophagus end portion 12 a and a stomach 20 usingan endoscopic anastomosis device 300 in accordance with some embodimentsprovided herein. The same devices and techniques described here tocreate the anastomosis between the esophagus 12 and stomach 12 can beused in other contexts as well. For example, such devices and techniquescan be used for scenarios such as, but not limited to, repair of colonresections, anastomosing esophageal portions, gastric bypass, bariatricanastomoses, vascular anastomoses, and the like.

In the depicted embodiment, endoscopic anastomosis device 300 includes abougie 310, a sheath 314, an obturator 320, and a stent 330. Obturator320 is releasably attached to the distal end portion of bougie 310.Stent 330 is releasably disposed circumferentially on a portion ofobturator 320. Sheath 314 is slidably engaged with bougie 310. A distalend portion of sheath 314 diametrically constrains stent 330 onobturator 320. As described further below, sheath 314 can be pulledproximally in relation to bougie 310 to release stent 330 from beingconstrained by the distal end portion of sheath 314. In someembodiments, a stent retention member is positioned on bougie 310 and/orobturator 320 that inhibits stent 330 from being displaced proximally assheath 314 is pulled proximally.

In some embodiments, bougie 310 is a typical flexible, reusable bougiedevice as is known in the art. In particular embodiments, bougie 310 isa custom device specifically made for use as part of endoscopicanastomosis device 300.

In some embodiments, obturator 320 is threadably attached to bougie 310.In some embodiments, obturator 320 is attached to bougie 310 usinganother fastening technique such as, but not limited to, using retainingclips, pinning, a bayonet connection, and the like. In some embodiments,obturator 320 is integral with bougie 310, i.e., not releasable.

In the depicted implementation, esophagus end portion 12 a has beencinched closed. The closure can be performed using techniques such as,but not limited to, installing one or more sutures (e.g., a purse-stringsuture, or figure eight suture), a lasso, a clip, and the like. With theesophagus end portion 12 a closed as shown, a clinician can maneuveresophagus 12 by manipulating bougie 310 and obturator 320.

In some implementations, obturator 320 may include an extended distaltip (e.g., a rod with a ball at the end, not shown) that becomescaptured within the cinched esophagus end portion 12 a. In such anarrangement, a clinician may be afforded the capability for even greatermaneuverability of esophagus 12 by manipulating bougie 310 and obturator320. In some implementations, obturator 320 may include a graspingdevice (not shown). Such a grasping device can be used to releasablycapture a portion of esophagus end portion 12 a to provide formaneuverability of esophagus 12 by manipulating bougie 310 and obturator320. In such a case, the need for cinching esophagus end portion 12 amay be unnecessary. In still another implementation, obturator 320 mayinclude a lasso device (not shown) that can be reversible deployed tocapture esophagus end portion 12 a to enable maneuverability ofesophagus 12 by manipulating bougie 310 and obturator 320. In yetanother implementation, obturator 320 may include one or more barbs (notshown) that can be reversible deployed to capture esophagus end portion12 a to enable maneuverability of esophagus 12 by manipulating bougie310 and obturator 320.

In the depicted embodiment, obturator 320 includes a tapered distal tipportion 322, a waist portion 324, and a proximal portion 326. In someembodiments, the outer diameter of waist portion 324 is less than themaximum outer diameter of distal tip portion 322 and proximal portion326. In result, a circumferential open space between stent 330 andobturator 320 exists in the area of waist portion 324.

Obturator 320, or portions thereof, can be made of various types ofmaterials. For example, in some embodiments obturator 320 is made ofmetallic materials such as, but not limited to, stainless steel,titanium, titanium alloys, and the like. In some embodiments, obturator320 is made of polymeric materials such as, but not limited to,polypropylene, polysulfone, polyetherimide, polyethersulfone,polyetheretherketone, and the like. In some embodiments, obturator 320is made of a combination of metallic and polymeric materials.

In some embodiments, obturator 320 is a single use, disposable item. Insome embodiments, obturator 320 is a reusable, sterilizable item.

In some embodiments, as in the depicted embodiment, proximal portion 326may include positional indicator 327. Positional indicator 327 can beused to identify a position and orientation of obturator 320 to aclinician (e.g., a position of waist portion 324 for the placement ofT-fasteners, as described further below). In some embodiments,positional indicator 327 is one or more light emitting elements (e.g.,LEDs). Such light emitting elements can trans-illuminate the esophagus(or other body structure) so that the clinician can ascertain theposition and orientation of obturator 320. In some embodiments, othertypes of positional indicators 327 (e.g., radiopaque markers) can beadditionally, or alternatively included.

Endoscopic anastomosis device 300 also includes stent 330. As describedfurther below, stent 330 acts as a buttress for the anastomosis. In someembodiments, stent 330 is a bioresorbable, biodegradable, orbioabsorbable stent. In some embodiments, stent 330 is a metallic stent(e.g., stainless steel or nitinol). In particular embodiments, stent 330may include a graft material that may be biodegradable or durable.Moreover, in various embodiments stent 330 may include an anti-refluxvalve (e.g., one-way valve) within the lumen of stent 330. Such a valvemay prevent or reduce the likelihood of reflux (e.g., GURD) in somescenarios. In some embodiments, stent 330 may include one or more anchordevices (e.g., hooks, prong, barbs, and the like). Stent 330 isconstructed so that T-fasteners can be passed through the wall of stent330, as described further below.

While stent 330 is depicted as having a certain length, it should beunderstood that in some embodiments the length of stent 330 is longer orshorter than depicted. For example, in some embodiments stent 330extends proximally along bougie 310 such that positional indicator 327is covered by stent 330. It should be understood that stent 330 can beconstructed in any suitable fashion such as, but not limited to,expanded material (e.g., a tube that is cut and then expanded), wovenstrands of material, a fabric, a mesh, and the like. In someembodiments, stent 330 is self-expanding. That is, in some embodimentsstent 330 is biased to expand diametrically when the constraint ofsheath 314 is removed from stent 330.

Sheath 314 is a flexible tube that is slidably engaged on bougie 310.

Accordingly, a clinician can selectively push and/or pull sheath 314distally and/or proximally, respectively, in relation to bougie 310 (andin relation to obturator 320 and stent 330). In some embodiments, sheath314 can be transparent or partially transparent.

A distal end portion of sheath 314 can at least partially encapsulateand thereby protect stent 330 during advancement of endoscopicanastomosis device 300 to a target location within patient 10. Once atthe target location, sheath 314 can be pulled proximally to reveal stent330. In some embodiments, stent 330 is prevented from being displacedproximally as sheath 314 is pulled proximally by a mechanical stopperfeature on bougie 310 or obturator 320.

Referring also to FIG. 14 , by manipulating bougie 310 (and obturator320 attached to bougie 310), a clinician can insert esophagus endportion 12 a into an opening in the wall of stomach 20 (in this exampleimplementation, or other body structure in other implementations).During this step, sheath 314 can remain in position such that it atleast partially encapsulates and protects stent 330.

Referring also to FIG. 15 , esophagus end portion 12 a is advanced intostomach 20 at least until waist portion 324 of obturator 320 is withinstomach 20. In this depiction, stomach 20 is shown in cross-section forbetter visibility of esophagus end portion 12 a within stomach 20.

When endoscopic anastomosis device 300 has been maneuvered to thedepicted orientation in relation to esophagus end portion 12 a andstomach 20, the clinician can then pull sheath 314 proximally inrelation to bougie 310 until stent 330 is fully revealed from withinsheath 314. In some cases, stent 330 may self-expand when revealed fromthe diametrically-constraining confines of sheath 314. In some cases,stent 330 does not self-expand.

Referring also to FIG. 16 , when the clinician has advanced esophagusend portion 12 a into stomach 20 to a desired relative position, andsheath 314 has been pulled off of stent 330, a plurality of T-fasteners340 a, 340 b, can be installed to create the anastomosis connectionbetween esophagus end portion 12 a and stomach 20. While the depictionincludes only two T-fasteners 340 a, 340 b, it should be understood thatany number of T-fasteners may be installed as shown around the peripheryof the anastomosis (so that a seal is created). In some implementations,positional indicator 327 is used by the clinician as a locationalreference for waist portion 324 so that T-fasteners 340 a, 340 b areinstalled in waist portion 324. Waist portion 324 provides a relievedarea of obturator 320 that physically accommodates the size ofT-fasteners 340 a, 340 b.

Each of the T-fasteners 340 a, 340 b is installed so that athree-layered wall is created around the periphery of the anastomosis.An innermost wall layer is esophagus end portion 12 a. An outer-mostwall layer is the wall of stomach 20. The middle layer of thethree-layered wall is stent 330. In this arrangement, stent 330strengthens the anastomosis and helps to facilitate an anastomosis witha complete and durable seal. That said, it should be understood thatstent 330 is optional. That is, in some embodiments no stent 330 isused.

Referring also to FIG. 17 , after placement of T-fasteners 340 a, 340 b,bougie 310 and obturator 320 are removed. Thereafter, the cinch isremoved from esophagus end portion 12 a. If a suture was used for thecinch, an endoscopic scissors or an argon plasma coagulator can be usedto remove the suture, for example. As shown, esophagus 12 is now in opencommunication with stomach 12.

In some embodiments, stent 330 and/or T-fasteners 340 a, 340 b arebioresorbable, biodegradable, or bioabsorbable. Hence, after a period oftime (such as an amount of time that allows the tissue of esophagus 12to attach with stomach 12) stent 330 and/or T-fasteners 340 a, 340 b maydeteriorate and be released from the area of the anastomosis. In someembodiments, stent 330 and/or T-fasteners 340 a, 340 b are notbioresorbable, biodegradable, or bioabsorbable. Hence, after a period oftime (such as an amount of time that allows the tissue of esophagus 12to attach with stomach 12) stent 330 and/or T-fasteners 340 a, 340 b maybe removed via a medical procedure (which may be endoscopic or minimallyinvasive).

While this specification contains many specific implementation details,these should not be construed as limitations on the scope of anyinvention or of what may be claimed, but rather as descriptions offeatures that may be specific to particular embodiments of particularinventions. Certain features that are described in this specification inthe context of separate embodiments can also be implemented incombination in a single embodiment. Conversely, various features thatare described in the context of a single embodiment can also beimplemented in multiple embodiments separately or in any suitablesubcombination. Moreover, although features may be described herein asacting in certain combinations and even initially claimed as such, oneor more features from a claimed combination can in some cases be excisedfrom the combination, and the claimed combination may be directed to asubcombination or variation of a subcombination.

Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. In certain circumstances, multitasking and parallel processingmay be advantageous. Moreover, the separation of various system modulesand components in the embodiments described herein should not beunderstood as requiring such separation in all embodiments, and itshould be understood that the described program components and systemscan generally be integrated together in a single product or packagedinto multiple products.

Particular embodiments of the subject matter have been described. Otherembodiments are within the scope of the following claims. For example,the actions recited in the claims can be performed in a different orderand still achieve desirable results. As one example, the processesdepicted in the accompanying figures do not necessarily require theparticular order shown, or sequential order, to achieve desirableresults. In certain implementations, multitasking and parallelprocessing may be advantageous.

What is claimed is:
 1. An endoscopic anastomosis device comprising: anendoscope with a plurality of working channels therethrough; a pluralityof T-fasteners, each T-fastener of the plurality of T-fasteners beingslidably disposable within a working channel of the plurality of workingchannels; and a plurality of sutures, wherein each T-fastener of theplurality of T-fasteners has a suture of the plurality of suturesattached thereto, wherein a distal end portion of each working channelof the plurality of working channels is configured to direct T-fastenersto emerge laterally from a distal tip portion of the endoscope at anangle from between about 45 degrees to about 90 degrees in relation to alongitudinal axis of the endoscope.
 2. The device of claim 1, whereinthe distal tip portion of the endoscope comprises a tapered leading end.3. The device of claim 1, wherein each T-fastener of the plurality ofT-fasteners has a beveled tip configured for puncturing tissue.
 4. Thedevice of claim 1, wherein the distal tip portion of the endoscopecomprises a tapered leading end, and wherein the plurality of workingchannels have open ends located at the tapered leading end.
 5. Thedevice of claim 1, wherein the plurality of working channels comprisesthree working channels.
 6. The device of claim 5, wherein the threeworking channels are distributed around a circumference of the distaltip portion of the endoscope.
 7. The device of claim 1, wherein theplurality of working channels comprises ten working channels.
 8. Thedevice of claim 7, wherein the ten working channels are distributedaround a circumference of the distal tip portion of the endoscope ineven angular increments.
 9. The device of claim 1, wherein the pluralityof working channels comprises six working channels.
 10. The device ofclaim 9, wherein the six working channels are distributed around acircumference of the distal tip portion of the endoscope in even angularincrements.
 11. The device of claim 1, wherein the plurality of workingchannels have end portions that are curved.